Disc Medicine, Inc. 8-K

What Happened

• On February 13, 2026, Disc Medicine, Inc. (NASDAQ: IRON) announced in a Current Report on Form 8‑K that the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) for the company’s New Drug Application (NDA) for bitopertin as a treatment for erythropoietic protoporphyria (EPP). The company attached a press release and the CRL as exhibits to the filing.

Key Details

• Date of filing and event: February 13, 2026 (Form 8‑K, Items 7.01 and 8.01).
• Regulatory action: FDA issued a Complete Response Letter for the bitopertin NDA (i.e., the application was not approved in its current form).
• Exhibits: Press release (Exhibit 99.1) and the CRL (Exhibit 99.2) were attached; portions of the CRL exhibit are omitted/redacted per SEC rules.
• Signature: Filing signed by CEO John Quisel, J.D., Ph.D.

Why It Matters

• A CRL means the FDA did not approve the NDA as submitted, so approval and any related commercialization or revenue from bitopertin will be delayed until Disc Medicine addresses the issues identified by the agency. Investors should monitor the company for follow-up disclosures on the CRL’s contents and the company’s planned next steps (e.g., additional data, meetings with the FDA, or resubmission), as these will determine the timeline and potential impact on the company’s development program and valuation.